Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
GlaxoSmithKline
Age
18–79
Sex
FEMALE
Healthy volunteers
Not accepted
You may be eligible if
Inclusion:
Informed consent: Subject is willing and able to provide written informed consent.
Menopausal status: Ambulatory female aged \< 80 years at screening and \>5 years postmenopausal.
T-Score: A subject with either no or only one prevalent vertebral fracture is eligible for inclusion if she satisfies one of the following T-score requirements:
If no prevalent vertebral fracture subject must have an absolute BMD value consistent with a T-score of less than or equal to -2.5 and greater than -4.0 at either the femoral neck, total hip, trochanter, or lumbar spine, or If one prevalent vertebral fracture subject must have an absolute BMD value consistent with a T-score of less than or equal to -2.0 and greater than -4.0 at either the femoral neck, total hip, trochanter, or lumbar spine.
Suitable vertebra: Two or more vertebra in the range of L1 to L4 that are suitable for BMD measurement by DXA.
Protocol compliance: Subject who, in the opinion of the investigator, is willing and able to comply with the requirements of the protocol.
Exclusion:
T-Score: Has an absolute BMD value consistent with a T-score less than or equal to -4.0 at either the femoral neck, total hip, trochanter, or lumbar spine.
Vertebral fractures: Has \>1 prevalent vertebral fracture at the screening visit.
Non-vertebral fractures: Any previous non-vertebral osteoporosis related/fragility fracture after age 40.
Spine deformity: Significant spine deformity which would preclude DXA/QCT assessments.
BMI: BMI ≥33kg/m2.
Bone metabolic diseases: Other than osteoporosis, history or concurrent diseases affecting bone metabolism (e.g., osteomalacia, hyperparathyroidism, hyperthyroidism).
GI disease: History of major upper gastrointestinal disease
Malabsorption: Active or history of malabsorption (e.g., history of celiac disease, irritable bowel syndrome or inflammatory bowel disease).
Liver disease: Past or current history of liver disease or known hepatic or biliary abnormalities, (with the exception of previously documented diagnosis of Gilbert's syndrome).
Rheumatoid arthritis: Active disease or history of rheumatoid arthritis.
Nephrolithiasis: History of or active nephrolithiasis (kidney stones).
Osteosarcoma risk: Subjects at increased risk of osteosarcoma such as those with Paget's disease of bone or any prior external beam or implant radiation therapy involving the skeleton.
Malignancy: Malignant disease diagnosed within the previous 5 years (except resected basal cell cancer).
Biological abnormalities: Any clinically relevant biological abnormality found and/or volunteered at screening (other than those related to the disease under investigation) which, in the opinion of the investigator, is clinically significant and would preclude safe participation in this study.
Surgical and medical conditions: Presence of the following conditions within six months prior to screening: myocardial infarction, coronary bypass surgery, coronary artery angioplasty, unstable angina, cardiac arrhythmia, clinically evident congestive heart failure, or cerebrovascular accident.
Glomerular filtration rate: Glomerular filtration rate (GFR) \<35 mL/min as calculated by the Modification of Diet in Renal Disease (MDRD) equation as follows: GFR (mL/min/1.73 m2) = 186 x (Serum creatinine mg/dL)-1.154 x (Age)-0.203 x (0.742 if female) x (1.210 if African American) (conventional units).
QT/QTc prolongation: A marked baseline prolongation of QT/QTc interval (e.g., QTc interval ≥450 msec on the Screening ECG).
Torsades de Pointes: A history of risk factors for Torsades de Pointes (e.g., heart failure, hypokalemia, family history of Long QT Syndrome).
Liver chemistries: Liver chemistries \[aspartate aminotransferase (AST), alanine aminotransferase (ALT) or total bilirubin\] exceeding 2-fold the upper limit of the laboratory-specified reference range, at screening.
Abnormal serum calcium: Serum calcium (total or albumin-adjusted) outside the central laboratory reference range at the screening visit.
Abnormal PTH: PTH (intact or whole) outside the normal range.
Abnormal creatine phosphokinase: Creatine phosphokinase (CPK) outside the normal range.
Abnormal alkaline phosphatase: Alkaline phosphatase outside of the normal range.
Thyroid hormone replacement: Subjects receiving thyroid hormone replacement therapy must have a TSH level checked. Subjects will be excluded if TSH levels are \<0.1 or \>10.0mIU/L. However, subjects will not be excluded if TSH is in the range 0.1-4.5 mIU/L. If TSH is \>4.5 and ≤10.0mIU/mL, measure T4 and exclude the subject only if the T4 is outside the normal range.
Vitamin D deficiency: Vitamin D deficiency (serum 25-hydroxy vitamin D \< 20ng/mL, equivalent to 50nmol/L) at screening. Subjects can undergo vitamin D repletion as per local practice and be re-screened once only for vitamin D levels within the 6-week screening period. They will remain excluded if the re-screened value is \< 20ng/mL.
Previous strontium or IV bisphosphonate: Any previous treatment with strontium ranelate or intravenous bisphosphonate.
Oral bisphosphonates: Any previous treatment with an oral bisphosphonate as follows:
any treatment within the last six months
one month cumulative treatment within the last 12 months
three months cumulative treatment within the past two years, or
two years cumulative treatment within the past five years.
* Fluoride: Treatment with fluoride (dose greater than 10mg/day) within the previous 5 years for osteoporosis.
* Digoxin: Current therapy with digoxin.
* Bone metabolism drugs: Treatment with other drugs affecting bone metabolism within the last six months prior to screening:
Chronic systemic corticosteroid \[e.g., glucocorticoid, mineralocorticoid\] treatment of no more than 2 intra-articular injections within the past year or use of oral, parenteral, or long-term, high-dose inhaled corticosteroids. Treatment with any topical corticosteroid will not exclude the subject from participating.
Hormones \[e.g., estrogens/"natural estrogen preparations"(except for nonsystemic vaginal treatment), 19-norprogestins, SERMs such as raloxifene, anabolic steroids/androgens such as dehydroepiandrosterone (DHEA) or its sulfated form (DHEAS), nandrolone, tibolone, active vitamin D analogs/metabolites such as 1,25-dihydroxy vitamin D (calcitriol) or 1alpha-hydroxyvitamin D3 (1-alpha hydroxycholecalciferol), calcitonin\].
Calcineurin inhibitors \[e.g., cyclosporine, tacrolimus\] or methotrexate.
Previous anabolic agents: Treatment with PTH, PTH analogues or similar anabolic agent for osteoporosis within the last two years.
Contraindications: Contraindications to therapy with calcium or vitamin D.
Pregnancy: Women who are pregnant are not allowed in this study.
Interfering medications: Vitamin A in excess of 10,000 IU per day, heparin, or lithium, or anticonvulsant medications except benzodiazepines.
Investigational drug exposure: Administration of any investigational drug within 90 days preceding the first dose of the study drug.
Substance abuse: History or current evidence of drug or alcohol abuse within the previous 12 months.
Problems swallowing: Inability to swallow a tablet whole.
You may not be if
Calcium channel blockers: Current therapy with calcium channel blockers diltiazem and verapamil.
Oral Azole Antifungals: Current therapy with any oral azole antifungal.
Immunosuppressants: Current therapy with cyclosporine or oral tacrolimus.
Ritonavir: Current therapy with ritonavir.
Quinidine: Current therapy with quinidine.
Macrolide Antibiotics: Subjects anticipated to require chronic use of macrolide antibiotics.
Hip surgery: History of hip surgery resulting in a metal implant on either the left or right side that would cause an artefact on a QCT scan.
Teriparatide contraindications: Contraindications to therapy with teriparatide according to locally approved datasheet.
Clareo Health | A Phase II Study Evaluating SB-751689 in Post-Menopausal Women With Osteoporosis.
